Apremilast versus Methotrexate In Moderate To SeverePsoriasis : A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 and PASI 75
研究概览
简要总结
AIM:
To compare and evaluate the efficacy, safety and compliance of oral apremilast to oral methotrexate in moderate to severe plaque psoriasis patients.
OBJECTIVES:
To compare and evaluate the clinical efficacy of oral apremilast to oral methotrexate in psoriasis
To evaluate the clinical safety and adverse effect of both the drugs
To assess tolerability and patient compliance to the both the drugs
STUDY SETTING: Teaching hospitals attached to the Medical College this study is conducted in.
STUDY DESIGN: Prospective , Non-interventional, Observational, Comparative study
DATA COLLECTION AND METHODOLOGY
Patients who fit the inclusion criteria are approached and informed regarding the nature and purpose of study. Those who are voluntarily willing to participate in the study will be enrolled. Written informed consent will be taken.
As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with daily clinical practice.
Moderate to Severe Plaque psoriasis patient who fit the inclusion criteria and who are started either on oral apremilast 30mg (BD) or oral methotrexate 5mg-15mg/week are considered for the study.
-Baseline demographics, disease characteristics and medication history prior to the start of treatment will be collected.
-Complete Blood Count(CBC),Liver Function Test (LFT) and Renal Function (RFT),Chest Xray and Urine analysis will be done on Day 0
-CBC and LFT will be repeated on completion of week 1,4,8 and 16 from the initiation of treatment.
-Patient will followed up for a duration of 16 weeks from treatment.
Outcome Variables:
Skin-specific diseasemeasures25 will be assessed on baseline visit and during scheduledfollow ups
-PsoriasisActivity and Severity Index (PASI)
-PhysicianGlobal Assessment (sPGA)
-BodySurface Area (BSA)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of moderate to severe plaque psoriasis defined by BSA > 10 or PASI > 10 or DLQI >10
- •Patients who are candidates for systemic therapy for psoriasis
- •Inadequate response to a previous systemic treatment
- •In good health as judged based on medical history, physical examination, serum chemistry labs, haematology values, and urinalysis.
- •Subjects are competent to sign and give informed consent
- •Subjects who willing to adhere to the Protocol and visit schedule.
排除标准
- •1.Patients with non-plaque forms of psoriasis (erythrodermic, guttate, pustular) 2.Pregnant or lactating women 3.Patients who had received any systemic treatment for psoriasis within 4 weeks of the baseline visit and topical treatment within the past 2 weeks of the baseline visit .
- •4.Phototherapy ultraviolet A with psoralen [PUVA] within 4 weeks of the baseline visit and/or ultraviolet B (UVB) within 2 weeks of the baseline visit 5.History of serious hypersensitivity to phosphodiesterase type 4 (PDE-4) inhibitors 6.Subjects with history of suicidal thought or other clinically significant psychiatric diseases 7.History of k/c/o congenital or acquired immunodeficiencies -HIV,Malignancy,Hepatitis B or C and other severe infection 8.Subject history of active tuberculosis infection or incompletely treated active or latent tuberculosis infection 9.Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
结局指标
主要结局
1)Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 and PASI 75
时间窗: 16 weeks after initiation of treatment
3)Change from baseline in the disease activity scores in terms of PASI
时间窗: 16 weeks after initiation of treatment
2)Changes in body surface area (BSA)
时间窗: 16 weeks after initiation of treatment
次要结局
- 2)Proportion of patients with Dermatology Life Quality Index (DLQI) ≤5(3)Rate of discontinuation of treatment)
- 1)Changes in static physician global assessment (sPGA)(At baseline and at 16weeks)